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U.S. Department of Health and Human Services

Class 2 Device Recall Pointe Scientific

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 Class 2 Device Recall Pointe Scientificsee related information
Date Initiated by FirmJune 12, 2006
Date PostedAugust 30, 2006
Recall Status1 Terminated 3 on November 19, 2007
Recall NumberZ-1458-06
Recall Event ID 35497
510(K)NumberK992002 
Product Classification Cholesterol Reagent Set - Product Code CCH
ProductAuto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L .
Code Information Lots 523002, exp. 2/07, and 531801, exp. 2/07.
Recalling Firm/
Manufacturer
Pointe Scientific, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact
734-487-8300
Manufacturer Reason
for Recall
Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
FDA Determined
Cause 2
Other
ActionConsignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.
Quantity in CommerceTo be determined
DistributionWorldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CCH
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